Quality Associate - Health Special Projects
Santa Clara Valley (Cupertino), California, United States
Operations and Supply Chain
The Health Special Projects group is looking for a Quality Associate (QA) to lead development and sustaining efforts for health technology related projects.
- 5+ years of medical device experience in a quality/compliance role
- Familiarity with 21 CFR 820, ISO-13485, and other applicable regulations
- You will have experience interpreting requirements and writing procedures
- Experience deploying and validating electronic systems for use in a regulated environment
- Exceptional organizational and management skills
- Excellent interpersonal skills, both verbal and written
QA's are responsible for deploying, managing, and updating necessary procedures in both a sustaining and ad hoc environment. Therefore, you will be able to: - Generate project plans with achievements, project schedules, and project status in the development of quality system attributes. - Partner with cross-functional teams to develop a validation system that accommodates for both planned and unplanned updates to critical electronic systems - Prioritize issues and track the details, as well as be in touch with the big picture issues. We are looking for someone who is flexible and can respond quickly and enthusiastically to changes. Additionally, cross-functional interpersonal skills and experience are critical to success in this role. This person will interact with all engineering design disciplines, data analysis, and additional project management teams. You will be responsible for: - Maintaining communication within the feasibility team - Preserving project schedules - Cross-functional organization, communication, and management - Crafting meetings and documenting action items and progress - Reporting and presenting to senior management on project status and schedules.
Education & Experience
B.S. ME/EE/BME/CS degree or equivalent in any engineering discipline
- Certified Lead Audit for ISO-13485, 21 CFR 820, etc,.
- Built or assisted in building a novel quality system from the ground up
- Own CAPA's
- Experience in working on software products within a quality or regulatory system
- Apple is an Equal Opportunity Employer that is committed to inclusion and diversity. We also take affirmative action to offer employment and advancement opportunities to all applicants, including minorities, women, protected veterans, and individuals with disabilities. Apple will not discriminate or retaliate against applicants who inquire about, disclose, or discuss their compensation or that of other applicants.